On September 25, the U.S. Food and Drug Administration (FDA) approved the insulins Tresiba and Ryzodeg 70/30, both manufactured by Novo Nordisk, to control blood sugar levels in adults with Type 1 or Type 2 diabetes. An estimated 29 million people in the United States are currently living with diabetes.
Tresiba, the brand name of insulin degludec, is a once-daily basal (long-acting) insulin analog with a half-life of 25 hours and a duration of action of at least 42 hours. Because of its extended coverage, it is the first long-acting insulin that does not need to be taken at the same time each day.
The safety and effectiveness of Tresiba in combination with mealtime insulin for people with Type 1 diabetes were established in two 26-week trials and one 52-week trial involving 1,102 participants. The safety and effectiveness of the medicine in combination with mealtime insulin or oral diabetes medicines for people with Type 2 diabetes were established in four 26-week and two 52-week trials involving 2,702 participants. The results showed that participants whose blood sugar was not under control experienced reductions in HbA1c (a measure of blood sugar control over the previous 2–3 months) comparable with other long-acting insulins.
Ryzodeg contains both insulin degludec and insulin aspart, a rapid-acting insulin analog, and is taken once or twice daily with a main meal.
The safety and effectiveness of Ryzodeg in combination with mealtime insulin for people with Type 1 diabetes were established in one 26-week trial involving 362 participants. The safety and effectiveness of the medicine taken once or twice daily for people with Type 2 diabetes were established in four 26-week trials involving 998 participants. The results showed that participants whose blood sugar was not under control experienced reductions in HbA1c comparable with other long-acting or premixed insulins.
Tresiba is expected to be launched in the first quarter of 2016 and will be available in the FlexTouch insulin pen, offered in two concentrations (U-100 and U-200) that enable maximum doses of 80 units and 160 units, respectively.
The most commonly reported side effects of Tresiba and Ryzodeg include hypoglycemia (low blood sugar), allergic reactions, injection site reactions, pitting at the injection site, itching, rash, swelling, and weight gain. The medicines should not be used by those who have diabetic ketoacidosis (increased ketones in the blood or urine).
“Long-acting insulins play an essential role in the treatment of patients with Type 1 diabetes and patients with Type 2 diabetes with advanced disease,” noted Jean-Marc Guettier, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.
An ongoing trial to evaluate the cardiovascular safety of insulin degludec is expected to be completed in the second half of 2016.
For more information about these insulins, see the press releases on the FDA or Novo Nordisk websites or the article “FDA Approves Long-Lasting Insulin Drugs Tresiba and Ryzodeg.”